September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Safety and efficacy of ciclosporin 1 mg/mL cationic emulsion (CsA CE) over 12 months in patients with severe dry eye disease (DED) in the SANSIKA Phase III trial
Author Affiliations & Notes
  • Gysbert B Van Setten
    St Eriks Eye Hospital, Karolinska Inst/St Eriks Eye Hosp, Danderyd, Sweden
  • Francisco C Figueiredo
    Royal Victoria Infirmary, Newcastle University, Newcastle upon Tyne, United Kingdom
  • Andrea Leonardi
    Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua, Italy
  • Mourad Amrane
    Santen SAS, Evry, France
  • Jean-Sebastien Garrigue
    Santen SAS, Evry, France
  • Dahlia Ismail
    Santen SAS, Evry, France
  • Christophe Baudouin
    Quinze-Vingts National Ophthalmology Hospital, Paris, France
    UPMC University, Paris, France Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris, France
  • Footnotes
    Commercial Relationships   Gysbert Van Setten, Santen (C), Santen (R), Thea (C); Francisco Figueiredo, Santen (C), Thea (C); Andrea Leonardi, Alcon (C), Allergan (C), Santen (C), Sifi (C), Thea (C); Mourad Amrane, Santen SAS (E); Jean-Sebastien Garrigue, Santen SAS (E); Dahlia Ismail, Santen SAS (C); Christophe Baudouin, Alcon (I), Allergan (I), Santen (I), Thea (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 2865. doi:
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      Gysbert B Van Setten, Francisco C Figueiredo, Andrea Leonardi, Mourad Amrane, Jean-Sebastien Garrigue, Dahlia Ismail, Christophe Baudouin; Safety and efficacy of ciclosporin 1 mg/mL cationic emulsion (CsA CE) over 12 months in patients with severe dry eye disease (DED) in the SANSIKA Phase III trial. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2865.

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      © ARVO (1962-2015); The Authors (2016-present)

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Purpose : Severe keratitis in DED increases the risk of ocular surface damage, vision loss and impaired quality of life. The objective here was to evaluate the safety and efficacy of CsA CE over 12 months in the SANSIKA Phase III trial.

Methods : SANSIKA was a multi-centre, 6-month double-masked (Part 1), randomized, vehicle-controlled, Phase III trial with a 6-month open-label extension period (Part 2) to evaluate the safety and efficacy of once-daily CsA CE in patients with severe DED (corneal fluorescein staining [CFS] Grade 4 on modified Oxford scale). All patients who completed Part 1 could receive CsA CE during Part 2. Patients were assessed for signs and symptoms of DED and safety.

Results : A total of 246 patients were randomized in the study, from which 207 patients continued onto Part 2 (128 continued with CsA CE [C/C] and 79 switched to CsA CE from vehicle at Month6 [V/C]); 177 patients completed Part 2. Mean CFS scores steadily decreased (improved) between baseline and 12 months in the C/C and V/C groups (–2.3 and –2.0, respectively). Complete corneal clearing was achieved by 12.5% of C/C patients and 11.4% of V/C patients at 12 months. Decrease from baseline at 12 months in the C/C and V/C groups was seen for mean ocular surface disease index score (–20.2 and –21.5, respectively) and median global visual assessment scale (VAS) score (–21.6 and –20.8, respectively). All eight symptoms in the VAS improved over the 12-month period in both groups. Reduction in ocular surface inflammation, as assessed by human leukocyte antigen-DR expression, was observed from baseline to Month 12 in C/C patients and from Months 6 to 12 in V/C patients. Overall, treatment effects in patients receiving CsA CE in Part 1 were either maintained or further improved during the last 6 months (Part 2). Treatment-related adverse events (AEs) were reported in a higher proportion of V/C patients than C/C patients and were ocular and mild to moderate in severity. Instillation-site pain was the most frequently reported treatment-related ocular AE. Frequency of severe ocular AEs and discontinuation due to ocular AEs were similar in both groups.

Conclusions : CsA CE for up to 12 months was safe and well tolerated and resulted in continuous improvement in corneal staining, ocular surface inflammation and symptoms in patients with DED and severe keratitis.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.


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